MHRA states intention to authorise GS1 standards
In response to support for the adoption of Global Trade Item Numbers (GTINs) in healthcare, the MHRA has stated its intention to authorise the use of GS1 standards to uniquely identify medical devices and enhance patient safety.
The announcement follows the MHRA’s consultation on the future regulation of medical devices in the UK which asked healthcare professionals and institutions, businesses, trade associations and patients for their views on the classification and identification of devices, manufacturers, and suppliers.
80% of respondents advocated the use of GS1 data standards such as GTINs to identify, track, and trace medical devices across healthcare supply chains from manufacture right through to the point of care.
As a result, the MHRA will authorise GS1 as an issuing entity for UDI, supporting the government’s strategy for strengthening regulation, improving patient safety, and providing consistency for manufacturers and healthcare providers alike.
The MHRA’s new UDI system will align with existing international regulations to provide a globally harmonised framework for medical device identification. This will reduce the risk of clinical error and allow for swift product recalls in the event of potentially harmful devices entering the market.
Based on the consultation’s recommendations, the government will:
- Require all manufacturers of medical devices to assign Unique Device Identifiers such as GS1 Global Trade Item Numbers (GTINs) to all products
- Require all reusable devices to bear a scannable UDI carrier such as barcode or Radio Frequency Identification (RFID) tag
- Issue essential requirements and guidance for Basic UDI device identifiers (BUDI-DI), to ensure the rationale for, and value of, collecting this information is clear
The government also intends to use data standards to uniquely identify manufacturers, UK Responsible Persons, importers, and distributors, who will all be required to register with the MHRA. The consultation offered three options – DUNS, GS1 and the MHRA’s own identifier – and more than one third of respondents favoured the use of GS1 standards.
The MHRA will collaborate with stakeholders to gradually refine legislation and ensure that their ambitious, transformational programme of reform allows both industry and healthcare providers to adapt to future changes.
Glen Hodgson, head of healthcare at GS1 UK said: “More than 90% of medical device manufacturers are already using GTINs as the primary identifier in the United States’ FDA Global Unique Device Identification Database. Couple this with the fact that GS1 is already authorised as an issuing entity for many other international medical device regulations, we are pleased to see the MHRA align on this matter.
“We will continue to support our members with the adoption of GS1 standards to ensure consistency and standardisation across the board. It is a key part of ensuring traceability and more importantly, patient safety.”